A Study of Perjeta (Pertuzumab) in Combination With Herceptin (Trastuzumab) and Chemotherapy in Patients With HER2-Positive Metastatic Gastroesophageal Junction or Gastric Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01774786
First received: January 21, 2013
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

This double-blind, placebo-controlled, randomized, multicenter, international, p arallel arm study will evaluate the efficacy and safety of Perjeta (pertuzumab) in combination with Herceptin (trastuzumab), fluoropyrimidine and cisplatin as f irst-line treatment in patients with HER2-positive metastatic gastroesophageal j unction or gastric cancer. Patients will be randomized to receive Perjeta 840 mg or placebo intravenously (iv) every 3 weeks in combination with Herceptin (init ial dose of 8 mg/kg iv followed by 6 mg/kg iv every 3 weeks) and cisplatin and f luoropyrimidine (capecitabine or 5-fluorouracil) for the first 6 treatment cycle s. Patients will continue to receive Perjeta or placebo and Herceptin until dise ase progression or unacceptable toxicity occurs.


Condition Intervention Phase
Gastric Cancer
Drug: pertuzumab [Perjeta]
Drug: placebo
Drug: trastuzumab [Herceptin]
Drug: cisplatin
Drug: capecitabine
Drug: 5-fluorouracil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER PHASE III STUDY EVALUATING THE EFFICACY AND SAFETY OF PERTUZUMAB IN COMBINATION WITH TRASTUZUMAB AND CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE METASTATIC GASTROESOPHAGEAL JUNCTION OR GASTRIC CANCER

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Overall survival: Time from randomization to death of any cause [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival: Time from randomization to first occurrence of disease progression, as determined by the investigator according to RECIST v1.1 criteria, or death of any cause [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Overall objective response (partial response + complete response) occurring on two consecutive occasions >/= 4 weeks apart, as determined by the investigator according to RECIST v1.1 criteria [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Duration of objective response: Time from occurrence of objective response to progressive disease, as determined by investigator according to RECIST v1.1 criteria, or death of any cause [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Clinical benefit rate: Best response of complete response or partial response or stable disease for 6 weeks or longer, as determined by the investigator according to RECIST v1.1 criteria [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of left ventricular systolic dysfunction (symptomatic or asymptomatic) [ Time Frame: approximately 4.5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 780
Study Start Date: June 2013
Estimated Study Completion Date: March 2022
Estimated Primary Completion Date: March 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pertuzumab + TFP Drug: pertuzumab [Perjeta]
840 mg iv every 3 weeks
Drug: trastuzumab [Herceptin]
8 mg/kg iv initial dose on Day 1, followed by 6 mg/kg iv every 3 weeks
Drug: cisplatin
80 mg/m2 iv every 3 weeks, 6 cycles
Drug: capecitabine
1000 mg/m2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) every 3 weeks, 6 cycles (or 5-fluorouracil)
Drug: 5-fluorouracil
800 mg/m2/24 hours iv by continuous infusion for 120 hours (Days 1-5) every 3 weeks, 6 cycles (or capecitabine)
Placebo Comparator: Placebo + TFP Drug: placebo
pertuzumab placebo iv every 3 weeks
Drug: trastuzumab [Herceptin]
8 mg/kg iv initial dose on Day 1, followed by 6 mg/kg iv every 3 weeks
Drug: cisplatin
80 mg/m2 iv every 3 weeks, 6 cycles
Drug: capecitabine
1000 mg/m2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) every 3 weeks, 6 cycles (or 5-fluorouracil)
Drug: 5-fluorouracil
800 mg/m2/24 hours iv by continuous infusion for 120 hours (Days 1-5) every 3 weeks, 6 cycles (or capecitabine)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction
  • Measurable or evaluable non-measurable disease as assessed by the investigator according to RECIST v1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Life expectancy >/= 3 months

Exclusion Criteria:

  • Previous cyctotoxic chemotherapy for advanced (metastatic) disease
  • Evidence of disease progression documented within 6 months after completion of prior neoadjuvant or adjuvant cytotoxic chemotherapy, or both, or radiotherapy for GEJ adenocarcinoma
  • Previous treatment with any HER2-directed therapy, at any time, for any duration
  • Previous exposure to any investigational treatment within 30 days before the first dose of study treatment
  • Radiotherapy within 30 days before the first dose of study treatment (within 2 weeks if given as palliation to peripheral bone metastases, if recovered from all toxicities)
  • History or evidence of brain metastases
  • Clinically significant active GI bleeding (Grade >/= 2 according to NIC-CTCAEv.4.03)
  • Other malignancy (in addition to GC) within 5 years before enrollment, except for carcinoma in situ of the cervix or squamous or basal cell carcinoma of the skin that has been previously treated with curative intent
  • Inadequate hematologic, renal or liver function
  • Pregnant or lactating women
  • History of congestive heart failure of any New York Heart Association (NYHA) criteria
  • Angina pectoris requiring treatment
  • Myocardial infarction within the past 6 months before the first dose of study drug
  • Clinically significant valvular heart disease or uncontrollable high-risk cardiac arrhythmia
  • History or evidence of poorly controlled hypertension
  • Baseline left ventricular ejection fraction (LVEF) value < 55%
  • Any significant uncontrolled intercurrent systemic illness
  • Positive for hepatitis B, hepatitis C or HIV infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01774786

Contacts
Contact: Reference Study ID Number: BO25114 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 188 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01774786     History of Changes
Other Study ID Numbers: BO25114
Study First Received: January 21, 2013
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Trastuzumab
Capecitabine
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 24, 2014